Glucose Homeostasis Pre and Post Bariatric Surgery (RB)
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Purpose
The investigators wish to study the effects of two forms of bariatric surgery, gastric bypass and lap banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
| Condition | Intervention |
|---|---|
|
Morbid Obesity |
Procedure: gastric bypass Procedure: gastric banding |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis |
- The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass and laparoscopic adjustable banding) on insulin action [ Time Frame: at 20% weight loss post surgery ] [ Designated as safety issue: No ]
- The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding) on pancreatic beta cell response [ Time Frame: at 20% weight loss post surgery ] [ Designated as safety issue: No ]
- Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding) on gut microbiota. [ Time Frame: at 20% weight loss post surgery ] [ Designated as safety issue: No ]
- Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery [ Time Frame: at 20% weight loss post surgery. ] [ Designated as safety issue: No ]
- Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction [ Time Frame: at 20% weight loss post surgery ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
plasma, tongue tissue, muscle tissue, fat tissue,liver tissue, colon tissue, stool
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Gastric Bypass
morbidly obese subjects undergoing gastric bypass surgery
|
Procedure: gastric bypass
Roux-en-Y gastric bypass
|
|
gastric banding
morbidly obese subjects undergoing laparoscopic gastric banding surgery
|
Procedure: gastric banding
laparoscopic adjustable gastric banding
|
Detailed Description:
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after Roux-en-Y gastric bypass (RYGB) surgery has led to the hypothesis that bypassing the upper gastrointestinal (GI) tract has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A total of 20 morbidly obese (BMI ≥ 35 kg/m2) subjects scheduled for bariatric surgical procedures will participate in this study.
Inclusion Criteria:
- BMI ≥ 35 kg/m2
- on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies
Exclusion Criteria:
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestinal disease
- diabetes mellitus
- show signs of oral disease or xerostomia (i.e., dry mouth)
- history of chronic rhinitis
- on medication that might affect metabolism
- severe organ dysfunction
Contacts and Locations| Contact: Courtney Tiemann, R.D. | 314-362-8250 | ctiemann@dom.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Courtney Tiemann, R.D. 314-362-8250 ctiemann@wustl.edu | |
| Principal Investigator: Samuel Klein, M.D. | |
| Principal Investigator: | Samuel Klein, MD | Washington University School of Medicine |
More Information
No publications provided by Washington University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00981500 History of Changes |
| Other Study ID Numbers: | 09-0175 |
| Study First Received: | September 18, 2009 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
obesity gastric bypass gastric banding weight loss insulin sensitivity |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013